Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer

June 17, 2014 updated by: Alessandro Napoli, University of Roma La Sapienza

Magnetic Resonance-guided High-intensity Focused Ultrasound Treatment of Locally Advanced Pancreatic Cancer: Phase II Study for Pain Palliation and Local Tumor Control

Patients with unresectable pancreatic cancer in most of cases cannot benefit from percutaneous ablation modalities, due to high risk of procedure-related complications. Ultrasound-guided high intensity focused ultrasound (HIFU) ablation has been introduced as a feasible treatment option in these patients. However, in other anatomical regions US-guided HIFU has been replaced by the more accurate MR-guided focused ultrasound (MRgFUS) ablation, but the applicability of this latter technique to the treatment of pancreatic cancer is still unexplored. The aim of this study is to explore feasibility and clinical performance of MRgFUS ablation of unresectable pancreatic cancer. Two are the main end-points: Pain palliation and local tumor control.

As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate, non-invasive ablation modality even for unresectable pancreatic cancer although, to date, no cases of pancreatic MRgFUS ablation have been reported.

Study Overview

Status

Available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy
        • Available
        • Sapienza University of Rome, Policlinico Umberto I Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • biopsy proven unresectable pancreatic adenocarcinoma;
  • unable or not willing to undergo chemo-radiation therapy
  • Celiac plexus alcoholization failed to control pain symptoms

Exclusion Criteria:

  • contraindication to MR or general anesthesia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Investigators

  • Principal Investigator: alessandro napoli, Sapienza University of Rome, Policlinico Umberto I Hospital
  • Study Chair: carlo catalano, Sapienza University of Rome, Policlinico Umberto I Hospital
  • Study Director: michele anzidei, Sapienza University of Rome, Policlinico Umberto I Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 5, 2013

First Posted (Estimate)

February 8, 2013

Study Record Updates

Last Update Posted (Estimate)

June 18, 2014

Last Update Submitted That Met QC Criteria

June 17, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pancreafus-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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